The American medical app enters the regulatory era China is still in its infancy

American medical app into the regulatory era, China's related industries are still in the initial stage, the government regulation intervention or lag of two years, which means that if China wants to follow suit, it will be two years later to achieve.

The cost and product iterations of a developer are bound to increase once a medical app needs to face a similar review of drug and medical devices by the regulatory authorities. And that's a huge cost to some small medical app development teams.

The worries of the industry have become a reality. As Mr Obama formally signed the new Food and Drug Administration (FD) Security and Innovation Act in early July, the United States formally established FDA regulation of medical apps from the legal level.

South reporters noted that the U.S. new deal has been quickly transmitted to the other side of the ocean in China. For Chinese developers, it may be difficult to sell apps to the U.S. market without a good understanding of US regulatory mechanisms. Moreover, given that FD A's decision has always been the barometer of China's Food and Drug Administration (SFDA), will China "follow suit"?

The medical app developer has tens of thousands of

The increasing popularity of the application of smart phone a PP has been changing people's previous treatment habits. As long as a sick, people first thought is to find a doctor to prescribe medicine, and nowadays, just pick up the phone, open some medical care to ask a PP, some common diseases and medication regimens, drug efficacy and adverse reactions, have been easy to download.

According to Baosheng, chairman of the Biological valley, the data sent to reporters in China, is developing medical a PP company has 500~600 home to 20 people per company, the practitioners of tens of thousands of people.

But this fast-growing industry is bracing for a new test. Such a PP developed by Chinese companies, if they want to enter the U.S. market, is theoretically subject to the regulation of FD A in the US.

After the new FD a Security and Innovation Act was signed by Obama in early July, the United States has formally established, from the legal level, the regulation of FD A on the medical Class A pp.

According to a draft regulation drafted by the country last year, a PP, labeled, declared, advertised and spoken or written in terms of diagnosis, treatment and disease prevention, will be covered.

In the opinion of one industry, the regulation of medical a PP will come sooner or later. At present, some smartphones in the support of Medical a PP, has been able to measure blood sugar and blood pressure, and on this basis through the network to achieve telemedicine, which has the risk of misdiagnosis. In his view, "mobile terminals do whatever they want to do, and they are bound to lose control." Strengthening regulation is therefore a trend. ”

Because of the regulatory trend of FD A has been the wind vane of SFDA, bio-valley, good doctors and many of the domestic companies involved in the medical app has given high attention to this matter. Because, in the long run, China has the possibility to follow up. And the impact on the industry is obvious, according to the U.S. counterparts said that a medical a PP under the control of FD A to market, "need about 72 months and an additional 75 million dollars in expenditure ——— this probably accounted for the total development costs of 77%".

China follows "It's too early"?

"You may not have a detailed profit model, but you burn less money than you do in a business like electricity," he said. This is one of the factors that VCs are willing to invest in medical a pp. "A former agency that has provided financial services to a number of health care a PP companies in the country said in an interview with reporters in South China. It is clear that, in the light of the previous experience of the United States, the burning of money will become inevitable once it is brought under regulation.

Some companies in the industry are more willing to look for differences in the level of medical a PP's openness before China and the United States to prove that the current Chinese medical a PP industry does not need to be regulated.

Regulatory intervention is necessary before U.S. A PP walks in China. It's early on in China to talk about it. At present, the domestic medical a PP industry is still in its infancy, many are actually health-type a pp. The real-world medical app for patients is currently very few in the country, and few of us are doing it. For medical treatment A PP, doctors usually have their own professional judgment. "Good Doctor Online CEO Wang that.

The Baosheng of the Biological Valley also holds a similar view, in his view, the domestic medical app is still "floating in the sky." App is linked to the cloud and terminal industry, but now the domestic medical a PP has no cloud and terminal, just to the information push mainly, or the simplest business model.

"It is necessary to strengthen regulation, but at this stage in China there is no need for regulation or for the value of regulation." It is necessary for the industry to develop to the level of the United States in the future. In Europe and the United States, they developed a lot of medical a PP has been used to protect the human body, is related to disease. For example, a can turn mobile phone into a medical thermometer of a PP, if the user's actual body temperature is 39 ℃, and show only 37 ℃, that will cause great risk. "Zhang Baofa said.

To the industry's attitude, the aforementioned institutions bare the industry's concerns, he admitted: "If the tube early, the industry will not develop." Do you see any emerging industry in China developed by regulation? ”

The wind throws the hot

In the agency's eyes, China's medical app, the market has the potential, as long as the global scale of the industry and the pace of development, you can see the future of this industry.

According to statistics from the Healthit now website, sales of medical apps in the App Store rose 250% from 2010 to 2011.

The chief executive of Manhattan Capital, which has focused on medical investment, has cited some international data research company reports that by 2015, medical a PP and its derivative market will reach a scale of more than 50 billion U.S. dollars, the industry will explode in the next few years.

In fact, in recent years, the investment in this field has already been surging because of the bullish development potential of the industry.

Take a good doctor online, for example, the company had already entered the venture as early as 2007. And Clove Garden, Rui Medical companies have also got the money of venture capital.

According to the aforementioned institutional people, clove garden and good doctors are optimistic because the two companies with the Division in the field of the second place has been 5 to 10 times times the distance. The two companies are so bull because patients and doctors have been using their products and their databases have been updated. This is an advantage that no one else can replicate.

The policy is not the same as "time bomb"

According to an industry analyst who studies medical apps in the country, medical a PP is an infinitely bullish industry, in China, where a single company has no more than 500 million companies and a maximum of 200 million yuan.

In his opinion, China Medical a PP industry can develop to how far, mainly depends on how much the country can let go.

"Compared to the United States, domestic medical a PP will still have a certain gap." First, the terminal is already 10 months later than the United States, in addition, policy on medical a PP-related mobile medical policy is very tight. "In the opinion of the analyst, the reason why a good doctor can take a firm footing is that a good doctor is a platform that has been approved by the relevant departments." This kind of platform resources are scarce, because once free online registration platform application, there will be "inverted number" of the risk, then "online cattle" will be flying.

According to the industry, the domestic venture investment in the health of the app, its target customers must be a habit of paying high-end users. Because of the imbalance of medical resources, the demand for high-end medical care for high-end people is always there. But it is not clear what the policy bias is for the industry. This kind of uncertain policy, in fact, for the industry, is tantamount to a time bomb.

At present, and medical a PP-related private Doctors policy is not clear, doctors more practice is also thunder, rain. However, according to foreign experience, strengthen supervision, medical a PP quality will be more and more high, from the long-term development point of view, is certainly positive.

"We look forward to a standardized and innovative industry development environment." "A practitioner who declined to be named expects the National Drug Administration to consider incorporating medical a PP into regulation after 2 years."

Domestic Medical App Category

According to industry insiders, the current domestic medical app can be divided into the following categories:

1. The medical app developed by the traditional Internet or database company.

2. Mainly with a number of enterprise-class applications combined products, such as Case Management System a PP, with this a PP, doctors can use the ipad to ward rounds, the development of such a PP company directly to the hospital charges.

3. There are also some products that receive traffic through medical a PP and then implant ads on a PP, of course, due to fewer users and tighter supervision, such products are relatively small.

The above categories of companies, the general can be the wind to cast their sights, are the industry or subdivision of the field of the leaders.